FDA approves revised labeling for Azilect

JERUSALEM The Food and Drug Administration has approved revised prescribing information for a drug used to treat Parkinson’s disease that reduces the number of food and medicine restrictions for patients.

Teva Pharmaceutical Industries announced Monday that the agency had approved the revised labeling for Azilect (rasagiline) based on clinical data that confirmed the drug’s mechanism of action as a selective inhibitor of the enzyme monoamine oxidase-B, also known as MAO-B, when taken in the 1-mg and 0.5-mg doses. The new information reflects reduced concerns about using Azilect together with certain medications and foods.

Those include many OTC cough-and-cold medicines and foods with the amino acid tyramine, including soybean products, aged cheeses and air-dried and fermented meats, though patients taking MAO-B inhibitors such as Azilect are still advised to avoid foods with very high levels of tyramine.

“We are pleased with this important change in the prescribing information of Azilect as it removes a barrier for some physicians and some patients living with Parkinson’s disease,” Teva Neuroscience VP and general manager Jon Congleton said. “Physicians can now better focus on what is really most important, which is helping patients receive a proven efficacious and safe treatment, at diagnosis early in Parkinson’s disease, and throughout the course of the disease.”